VA Class:CN801
AHFS Class:
Generic Name(s):
- Dextroamphetamine Saccharate
- Dextroamphetamine Sulfate
Notification FDA drug safety communication (5/11/2023): To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is consistent across the entire class of these drugs.500 The current prescribing information in some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, particularly when these drugs are shared with individuals for whom they are not prescribed. 500 An FDA review found that most individuals who misuse prescription stimulants obtain their drugs from family members or peers, and that such sharing of prescription stimulants was a major contributor to nonmedical use and addiction.500 Updates will include information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class.500 The Boxed Warning will also advise healthcare professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.500 |
Dextroamphetamine is the dextrorotatory isomer of amphetamine.102
Dextroamphetamine sulfate alone and in fixed-combination preparations with dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate is used in the treatment of narcolepsy and as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD).
Narcolepsy and Attention Deficit Hyperactivity Disorder
Dextroamphetamine sulfate alone and in fixed-combination preparations with dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate is used in the treatment of narcolepsy and as an adjunct to psychological, educational, social, and other remedial measures in the treatment of ADHD (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction) in children, adolescents, and adults.
ADHD usually is characterized by developmentally inappropriate symptoms (e.g., moderate to severe distractibility, short attention span, hyperactivity, emotional lability, impulsivity). The final diagnosis of this disorder should not be made if these symptoms are of only comparatively recent origin. Nonlocalizing (soft) neurologic signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of CNS dysfunction may or may not be warranted. Drug therapy is not indicated in all children with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed. The decision to use amphetamines should depend on the age of the child and the clinician's assessment of the severity and duration of symptoms and should not depend solely on one or more behavioral characteristics. When symptoms of ADHD are associated with acute stress reactions, use of amphetamines usually is not recommended. For a more detailed discussion on the management of ADHD, including the use of stimulants such as dextroamphetamine, see Uses: Attention Deficit Hyperactivity Disorder, in Methylphenidate 28:20.32.
Administration 
Preparations containing dextroamphetamine sulfate are administered orally. The commercially available extended-release capsules containing dextroamphetamine sulfate and dextroamphetamine saccharate in fixed-combination with amphetamine sulfate and amphetamine aspartate (Adderall XR®) may be swallowed intact with or without food or the entire contents of a capsule(s) may be sprinkled on a small amount of applesauce immediately prior to administration; subdividing the contents of a capsule is not recommended.103 The pellets contained in the capsules should not be chewed or crushed, and the sprinkle/food mixture must not be stored for use at a later time.103
The initial dose of dextroamphetamine sulfate (alone or in fixed-combination preparations) is given on awakening; when the drug is given as conventional (short-acting) tablets in divided doses (2 or 3), additional doses are given at intervals of 4-6 hours. Because of the potential for insomnia, administration of dextroamphetamine sulfate conventional tablets (Dexedrine®), dextroamphetamine sulfate extended-release capsules (Dexedrine® Spansules®), or fixed-combination conventional tablets (Adderall®) in the late evening or administration of fixed-combination extended-release capsules (Adderall XR®) in the afternoon should be avoided.
Dosage
Dosage of dextroamphetamines should be adjusted according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.
Narcolepsy
In the treatment of narcolepsy, the usual dosage of dextroamphetamine sulfate given alone or the total dosage of amphetamines given in fixed-combination preparations containing dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate is 5-60 mg daily, depending upon the patient's age and response, usually given in divided doses. In patients 12 years of age and older, the initial dosage is 10 mg daily; daily dosage is increased by 10 mg at weekly intervals until the optimum response is attained. Although narcolepsy seldom occurs in children younger than 12 years of age, in pediatric patients 6-12 years of age, the recommended initial dosage of dextroamphetamine sulfate is 5 mg daily; daily dosage is increased by 5 mg at weekly intervals until the optimum response is attained. When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced. Dextroamphetamine sulfate extended-release capsules may be used for once-daily dosing whenever appropriate.
Attention Deficit Hyperactivity Disorder
Dextroamphetamine sulfate dosage for the treatment of attention deficit hyperactivity disorder (ADHD) should be individualized based on patient response and tolerance.100,101,102,103 The first dosage that produces an observable response may not be the optimum dosage to improve function, and titration to higher dosages should continue in an attempt to achieve a better response.100 Such a strategy may require subsequent lowering of dosage when higher dosages produce adverse effects or no further clinical improvement.100 The best dosage for a given patient is the one that provides optimum therapeutic effects with minimal adverse effects.100 Dosing schedules also may vary, although there currently are no consistent controlled studies comparing alternative dosing schedules.100 Patients who require relief only during school may respond adequately to a 5-day (i.e., school day) regimen while those requiring relief at home and school may need a daily regimen throughout the week.100
As an adjunct in the treatment of ADHD in children 6 years of age and older, the initial dosage of dextroamphetamine sulfate given in conventional (short-acting) preparations is 5 mg once or twice daily; daily dosage is increased by 5 mg at weekly intervals until the optimum response is attained. The usual dosage range is 5-15 mg twice daily or 5-10 mg 3 times daily.100 Total daily dosage rarely should exceed 40 mg. In children 3-5 years of age, the initial daily dosage is 2.5 mg; daily dosage is increased by 2.5 mg at weekly intervals until the optimum response is attained. When the drug is administered as conventional tablets in divided doses (2 or 3), additional doses are given at intervals of 4-6 hours. Dextroamphetamine sulfate extended-release capsules can be substituted for their respective conventional short-acting preparations if less frequent daily dosing is desirable.
Dextroamphetamine sulfate in fixed combination with other amphetamines (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate) also is used as an adjunct in the treatment of ADHD in children 6 years of age and older; the initial total dosage of amphetamines is 5 mg once or twice daily.101 The daily dosage is increased by 5 mg at weekly intervals until the optimum response is attained; total daily dosage rarely should exceed 40 mg.101 In children 3-5 years of age, the initial daily dosage is 2.5 mg; daily dosage is increased by 2.5 mg at weekly intervals until the optimum response is attained.101 The manufacturer recommends that the initial dose of dextroamphetamine sulfate in fixed combination with other amphetamines be given on awakening; additional doses (1 or 2) are given at intervals of 4-6 hours.101 The usual dosage for intermediate-acting preparations (e.g., Dexedrine® Spansules®, Adderall®) in children 6 years of age and older is 5-30 mg once daily or 5-15 mg twice daily.100
Alternatively, in patients who are receiving drug therapy for ADHD for the first time or are being switched from therapy with another stimulant, dextroamphetamine therapy may be initiated with extended-release capsules containing dextroamphetamine sulfate in fixed-combination with dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate (Adderall XR®). In children 6-12 years of age, the initial dosage of total amphetamines as fixed-combination extended-release capsules (Adderall XR®) is 10 mg once daily; daily dosage may be increased in increments of 5 or 10 mg at weekly intervals to a maximum dosage of 30 mg daily.103 Treatment may be initiated with a dosage of 5 mg once daily when, in the opinion of the clinician, a lower initial dosage is appropriate. The usual dosage for such longer-acting preparations (e.g., Adderall XR®) is 10-30 mg daily.100 In adolescents 13-17 years of age, the initial dosage of total amphetamines as fixed-combination extended-release capsules (Adderall XR®) is 10 mg once daily.103 Dosage may be increased to 20 mg once daily after 1 week if symptoms are not adequately controlled.103 In adults who are receiving drug therapy for ADHD for the first time or are being switched from therapy with another drug, the recommended dosage of amphetamines as fixed-combination extended-release capsules (Adderall XR®) is 20 mg once daily. Although dosages of up to 60 mg daily (as fixed-combination extended-release capsules) have been used in adolescents 13-17 years of age and adults in clinical studies, there is no evidence that dosages exceeding 20 mg daily provide any additional benefit in these patients.103 When switching from fixed-combination conventional tablets (Adderall®) to fixed-combination extended-release capsules (Adderall XR®), the total daily dosage of amphetamines may remain the same but should be given once daily.
When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment. Long-term use of fixed-combination extended-release capsules (i.e., more than 3 weeks in children or more than 4 weeks in adolescents or adults) has not been studied systematically. If fixed-combination extended-release capsules are used for extended periods, the usefulness of the drug should be periodically reevaluated.103
Dextroamphetamine shares the toxic potentials of amphetamines, and the usual cautions, precautions, and contraindications of amphetamine therapy should be observed. (See Cautions in the Amphetamines General Statement 28:20.04.)
Some commercially available preparations of dextroamphetamine (e.g., DextroStat®, Dexedrine® tablets) contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.
Chemistry and Stability
Chemistry
Dextroamphetamine is the dextrorotatory isomer of amphetamine. Dextroamphetamine sulfate occurs as a white, odorless, crystalline powder and has a bitter taste. Dextroamphetamine sulfate is freely soluble in water (about 1:10) and slightly soluble in alcohol (about 1:800). Dextroamphetamine sulfate also is commercially available as fixed-combination preparations with dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate.101,103
Stability
Preparations containing dextroamphetamine sulfate should be stored in tight, light-resistant containers at 15-30°C.101,102,103
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Dextroamphetamine and dextroamphetamine sulfate preparations are subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs.
Dextroamphetamine Sulfate
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|
Oral | Capsules, extended-release | 5 mg* | Dexedrine® Spansule® (C-II) | GlaxoSmithKline |
| | | Dextroamphetamine Sulfate Capsules SR (C-II) | |
| | 10 mg* | Dexedrine® Spansule® (C-II) | GlaxoSmithKline |
| | | Dextroamphetamine Sulfate Capsules SR (C-II) | |
| | 15 mg* | Dexedrine® Spansule® (C-II) | GlaxoSmithKline |
| | | Dextroamphetamine Sulfate Capsules SR (C-II) | |
| Tablets | 5 mg* | Dexedrine® (C-II; scored) | GlaxoSmithKline |
| | | Dextroamphetamine Sulfate Tablets (C-II; scored) | |
| | | DextroStat® (C-II, scored) | Shire |
| | 10 mg* | Dextroamphetamine Sulfate Tablets (C-II; scored) | |
| | | DextroStat® (C-II; double-scored) | Shire |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Dextroamphetamine Sulfate Combinations
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|
Oral | Capsules, extended-release | 5 mg total amphetamine (as 1.25 mg with Amphetamine Sulfate 1.25 mg, Amphetamine Aspartate 1.25 mg, and Dextroamphetamine Saccharate 1.25 mg) | Adderall XR® (C-II) | Shire |
| | 10 mg total amphetamine (as 2.5 mg with Amphetamine Sulfate 2.5 mg, Amphetamine Aspartate 2.5 mg, and Dextroamphetamine Saccharate 2.5 mg) | Adderall XR® (C-II) | Shire |
| | 15 mg total amphetamine (as 3.75 mg with Amphetamine Sulfate 3.75 mg, Amphetamine Aspartate 3.75 mg, and Dextroamphetamine Saccharate 3.75 mg) | Adderall XR® (C-II) | Shire |
| | 20 mg total amphetamine (as 5 mg with Amphetamine Sulfate 5 mg, Amphetamine Aspartate 5 mg, and Dextroamphetamine Saccharate 5 mg) | Adderall XR® (C-II) | Shire |
| | 25 mg total amphetamine (as 6.25 mg with Amphetamine Sulfate 6.25 mg, Amphetamine Aspartate 6.25 mg, and Dextroamphetamine Saccharate 6.25 mg) | Adderall XR® (C-II) | Shire |
| | 30 mg total amphetamine (as 7.5 mg with Amphetamine Sulfate 7.5 mg, Amphetamine Aspartate 7.5 mg, and Dextroamphetamine Saccharate 7.5 mg) | Adderall XR® (C-II) | Shire |
| Tablets | 5 mg total amphetamine (as 1.25 mg with Amphetamine Aspartate 1.25 mg, Amphetamine Sulfate 1.25 mg, and Dextroamphetamine Saccharate 1.25 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 7.5 mg total amphetamine (as 1.875 mg with Amphetamine Aspartate 1.875 mg, Amphetamine Sulfate 1.875 mg, and Dextroamphetamine Saccharate 1.875 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 10 mg total amphetamine (as 2.5 mg with Amphetamine Aspartate 2.5 mg, Amphetamine Sulfate 2.5 mg, and Dextroamphetamine Saccharate 2.5 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 12.5 mg total amphetamine (as 3.125 mg with Amphetamine Aspartate 3.125 mg, Amphetamine Sulfate 3.125 mg, and Dextroamphetamine Saccharate 3.125 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 15 mg total amphetamine (as 3.75 mg with Amphetamine Aspartate 3.75 mg, Amphetamine Sulfate 3.75 mg, and Dextroamphetamine Saccharate 3.75 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 20 mg total amphetamine (as 5 mg with Amphetamine Aspartate 5 mg, Amphetamine Sulfate 5 mg, and Dextroamphetamine Saccharate 5 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (C-II; double-scored) | |
| | 30 mg total amphetamine (as 7.5 mg with Amphetamine Aspartate 7.5 mg, Amphetamine Sulfate 7.5 mg, and Dextroamphetamine Saccharate 7.5 mg)* | Adderall® (C-II; double-scored) | Shire |
| | | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (C-II; double-scored) | |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions May 18, 2023. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
100. American Academy of Pediatrics Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical treatment guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics . 2001; 108:1033-44. [PubMed 11581465]
101. Shire US Inc. Adderall® (mixed salts of a single-entity amphetamine product) prescribing information (dated 2006 Jun). In: Physicians' desk reference online. Accessed 2006 Dec 6. [Web]
102. GlaxoSmithKline. Dexedrine® (dextroamphetamine sulfate) Spansule® sustained-release capsules and tablets prescribing information. Research Triangle Park, NC; 2007 Mar.
103. Shire US Inc. Adderall XR® (mixed salts of a single-entity amphetamine product) capsules prescribing information. Wayne, PA; 2007 Mar.
500. FDA drug safety communication. FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions; issued May 11 2023. From FDA website. [Web]